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Adding Group-Based Pain Neuroscience Education to a Community Exercise Program for Older Women With Knee Osteoarthritis

27. april 2026 opdateret af: Pontificia Universidad Catolica de Chile

Multidimensional Assessment of the Activities of the "Camina 60+" Program for the Promotion of Healthy Aging - Adding Group-Based Pain Neuroscience Education to a Community Exercise Program for Older Women With Knee Osteoarthritis: A Pilot Randomized Trial of Feasibility and Preliminary Effects.

This pilot trial aimed to estimate preliminary clinical effects and to assess the feasibility of adding group-based pain neuroscience education (PNE) to exercise in women aged ≥60 years with medically diagnosed knee osteoarthritis and current knee pain. Participants were randomized to either 10 weeks of community-based exercise plus PNE or exercise alone. All participants attended weekly group exercise sessions, and those in the intervention group also participated in five in-person group-based PNE sessions lasting 30 minutes each. Physical fitness tests were administered, and participants completed questionnaires assessing disability, pain intensity, and pain neurophysiology knowledge.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Knee osteoarthritis (OA) is a highly prevalent and disabling condition in older adults, with the knee being the most commonly affected joint. In Chile, OA represents a substantial clinical and public health burden, particularly among women aged 60 years and older, who experience high rates of pain, disability, and loss of functional independence. Disability and pain are hallmark symptoms of knee OA and are strongly associated with reduced physical function and poorer quality of life in older women. Current clinical guidelines recommend education, self-management, and exercise as first-line treatments. Exercise therapy can improve pain and physical function in people with knee OA, but average effects are modest and individual responses vary. Pain in knee OA is increasingly understood within a biopsychosocial framework, suggesting that maladaptive pain beliefs contribute to persistent symptoms. Pain Neuroscience Education (PNE) may complement exercise by improving pain-related knowledge and psychological outcomes, although evidence-particularly for group-based delivery and disability outcomes in older women-remains limited. This study was implemented in the context of a training program called "Camina 60+KineUC", a community-based program jointly delivered by the UC Older Adults Program and the Department of Physical Therapy from Pontificia Universidad Católica de Chile. The program provides weekly group sessions focused on strength, aerobic, balance, and flexibility exercises for adults aged 60 years and older and is designed to promote healthy aging. The study was designed to assess feasibility and estimate preliminary between-group effect sizes rather than to make definitive efficacy conclusions.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

19

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Chile
      • Santiago, Chile
        • Pontificia Universidad Catolica de Chile

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

- Medical diagnosis of knee osteoarthritis with current knee pain.

Exclusion Criteria:

  • Inability to understand study procedures during baseline assessment. Mini-Mental State Examination (MMSE) cutoff used to define adequate comprehension for study participation was ≥24/30).
  • Severe neurological disease.
  • Anticipated inability to attend all educational sessions or attendance less than 80% at the end of the program.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Exercise plus Pain Neuroscience Education
In addition to the 10-week Camina 60+KineUC exercise program, this group received five in-person group-based Pain Neuroscience Education (PNE) sessions lasting 30 minutes each. Sessions were delivered across the intervention period using standardized digital presentations, for a total dose aligned with evidence suggesting psychosocial benefits when PNE is combined with exercise. The intervention was delivered by four fourth-year physical therapy students trained in PNE, based on recognized educational resources. Intervention fidelity was ensured through prior training, use of standardized materials, and adherence to a prespecified session checklist.
Andet: Pain neuroscience education (PNE)
The intervention group received five group-based PNE sessions of 30 min each ((total dose = 150 min) delivered in person across the 10-week intervention period using digital presentations. The selected dose was informed by dose-response syntheses suggesting that 150-200 min of PNE may be associated with clinically relevant changes in psychosocial outcomes when combined with exercise. Sessions were delivered by four fourth-year physical therapy students trained in PNE and were based on The Knee Osteoarthritis Handbook (Noigroup©) and Dolor Crónico, una guía de ayuda para pacientes (Equipo DolorUC book). To support intervention fidelity, the student facilitators completed 5 days of 2hrs of training in PNE and communications skills before delivering the intervention, used a standardized slide deck and session script, and followed a prespecified checklist for each session.
Andet: Exercise program
The "Camina 60+KineUC" is a community-based program jointly delivered by the UC Older Adults Program and the Department of Physical Therapy of the Pontificia Universidad Católica de Chile. The program provides weekly group in-person sessions focused on strength, aerobic, balance, and flexibility exercises for adults aged 60 years and older, guided by monitors (physiotherapists and trained physiotherapy students), considering progression in movement complexity, or balance challenge according to tolerance, throughout the 10 weeks of the program.
Aktiv komparator: Exercise-only group
Camina 60+KineUC exercise program for 10 weeks, which consists of group exercise sessions delivered weekly, in person, and includes strength, aerobic, balance, and flexibility exercises. Each exercise session lasted 60min and was delivered by the monitors of Camina60+. Sessions included warm-up, strengthening, aerobic training, balance, and flexibility. Progression across the 10-week intervention period was standardized by movement complexity, or balance challenge according to tolerance. After study completion, they were offered the same group-based PNE program provided to the intervention group.
Andet: Exercise program
The "Camina 60+KineUC" is a community-based program jointly delivered by the UC Older Adults Program and the Department of Physical Therapy of the Pontificia Universidad Católica de Chile. The program provides weekly group in-person sessions focused on strength, aerobic, balance, and flexibility exercises for adults aged 60 years and older, guided by monitors (physiotherapists and trained physiotherapy students), considering progression in movement complexity, or balance challenge according to tolerance, throughout the 10 weeks of the program.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
KOOS - Activities of Daily Living (KOOS-ADL)
Tidsramme: Baseline and immediately after the 10-week intervention period.
Self-reported disability during activities of daily living, measured using the Activities of Daily Living subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS is a knee-specific, self-administered questionnaire. The ADL subscale is scored from 0 to 100, with higher scores indicating better knee-related function.
Baseline and immediately after the 10-week intervention period.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
KOOS - Pain Subscale
Tidsramme: Baseline and immediately after the 10-week intervention period.
Knee pain measured using the Pain subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS). Scores range from 0 to 100, with higher scores indicating less pain and better knee status.
Baseline and immediately after the 10-week intervention period.
KOOS - Symptoms Subscale
Tidsramme: Baseline and immediately after the 10-week intervention period.
Knee-related symptoms measured using the Symptoms subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS). Scores range from 0 to 100, with higher scores indicating fewer symptoms.
Baseline and immediately after the 10-week intervention period.
KOOS - Sport and Recreation Function Subscale
Tidsramme: Baseline and immediately after the 10-week intervention period.
Self-reported difficulty with sport and recreational activities measured using the Sport and Recreation Function subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS). Scores range from 0 to 100, with higher scores indicating better function.
Baseline and immediately after the 10-week intervention period.
KOOS - Knee-related Quality of Life Subscale
Tidsramme: Baseline and immediately after the 10-week intervention period.
Knee-related quality of life measured using the Quality of Life subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS). Scores range from 0 to 100, with higher scores indicating better knee-related quality of life.
Baseline and immediately after the 10-week intervention period.
Pain intensity
Tidsramme: Baseline and immediately after the 10-week intervention period.
Pain intensity was assessed with a 10-cm visual analog scale, with higher scores indicating greater pain intensity.
Baseline and immediately after the 10-week intervention period.
Lower-body functional performance
Tidsramme: Baseline and immediately after the 10-week intervention period.
Lower-body functional performance was assessed with the 30-s Sit-to-Stand Test, scored as the number of repetitions completed in 30 seconds.
Baseline and immediately after the 10-week intervention period.
Pain neurophysiology knowledge
Tidsramme: Baseline and immediately after the 10-week intervention period.
Pain neurophysiology knowledge was assessed with the Spanish version of the Revised Neurophysiology of Pain Questionnaire (R-NPQ), with higher scores indicating greater knowledge.
Baseline and immediately after the 10-week intervention period.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility - Screening and Recruitment
Tidsramme: From enrollment to the end of the 10-week intervention.
Number of participants assessed for eligibility, excluded, and randomized. Unit of Measure: Number of participants
From enrollment to the end of the 10-week intervention.
Feasibility - Retention
Tidsramme: From enrollment to the end of the 10-week intervention.
Retention defined as the proportion of randomized participants who completed the post-intervention assessment. Unit of Measure: Percentage of participants (%)
From enrollment to the end of the 10-week intervention.
Feasibility - Exercise Adherence
Tidsramme: From enrollment to the end of the 10-week intervention.
Exercise adherence defined as attendance at ≥80% of scheduled exercise sessions during the intervention period. Unit of Measure: Percentage of participants meeting adherence criterion (%)
From enrollment to the end of the 10-week intervention.
Feasibility - Attendance at Pain Neuroscience Education Sessions
Tidsramme: From enrollment to the end of the 10-week intervention.
Attendance defined as the number of group-based Pain Neuroscience Education (PNE) sessions attended (0-5) among participants allocated to the intervention group. Unit of Measure: Number of sessions attended
From enrollment to the end of the 10-week intervention.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pontificia Universidad Catolica de Chile

Efterforskere

  • Ledende efterforsker: Gustavo Torres, Pontificia Universidad Catolica de Chile

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2024

Primær færdiggørelse (Faktiske)

30. november 2024

Studieafslutning (Faktiske)

30. november 2024

Datoer for studieregistrering

Først indsendt

16. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 240131002

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

IPD-planbeskrivelse

The small sample size of the study may limit the ability to fully ensure participant confidentiality if individual-level data were to be shared.

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Kliniske forsøg med Smerte

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